L. Perrigo Co.
Form 483 issued March 19, 2025 · Allegan, Michigan
- Inspection
- Mar 10 – Mar 19, 2025
- Investigators
- Ana-Maria A. Plapcianu· Anna M. Spiros
- Observations
- 5
- Pages
- 4
- FEI number
- 1811666
In short: On March 19, 2025, FDA issued a Form 483 with 5 observations to L. Perrigo Co. in Allegan, Michigan (FEI 1811666) after an inspection that ran Mar 10 – Mar 19, 2025. The investigators were Ana-Maria A. Plapcianu and Anna M. Spiros. Most observations concern facilities & equipment and laboratory controls.
At a glance
3 of 5 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 02
The written stability program for drug products does not include reliable, meaningful…
- 03
There is a lack of written procedures describing in sufficient detail the handling of…
- 04
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in…
This inspection in context
Ana-Maria A. Plapcianu
4 documents · 2020–2026
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in California.
The firmL. Perrigo Co. history
All 14 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.68(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at L. Perrigo Co.?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, laboratory controls and packaging & labeling. The opening words of each observation are shown on this page.
Who inspected L. Perrigo Co.?
Ana-Maria A. Plapcianu and Anna M. Spiros are named on this Form 483, for the inspection of Mar 10 – Mar 19, 2025. Each investigator has a profile showing what they cite most.
When was L. Perrigo Co. inspected by FDA?
The inspection ran Mar 10 – Mar 19, 2025, and the Form 483 is dated March 19, 2025.
How do I get the full Form 483 for L. Perrigo Co.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.